Nordicneurolab AS FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
nordicAudio (1.0)510(k)Mar 20, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 20, 2026
nordicMEDiVA510(k)Oct 22, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 22, 2024
nordicMEDiVA510(k)Jun 28, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 28, 2024
fMRI Hardware System510(k)Dec 13, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 13, 2023
nordicDSC510(k)Mar 3, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 3, 2022